1、 215362013 ISO 21536:2007 Non-active surgical implants Joint replacement implants Specific requirements for knee-joint replacement implants (IDT) 215362013 II 1 ( ) , 4 2 453 3 85- 7 2013 . 4 21536:2007 . . (ISO 21536:2007 Non-active surgical implants Joint replacement implants Specific requirements
2、 for knee-joint replacement implants). , . 5 1.02012 ( 8). ( 1 ) , . () . , (gost.ru) , 2014 , 215362013 III , . ( 1 ): 1: , ; 2: ; 3: . 3 , . 1 . 2 3. 2 , , , , - . , , . 215362013 1 Non-active surgical implants Joint replacement implants Specific requirements for knee-joint replacement implants 20
3、141101 1 . , , , , , , , , . 2 : 7207-1 . . 1. , 14243-2 . . 2. . 14243-3 . . 3. . 14630 . . ISO 14879-1 . . 1. . ISO 21534:2007 . . . 3 21534 7207-1, : 3.1 , . - , . 3.2 , . , . 3.3 (), . 215362013 2 3.4 , 3.5 (), . 3.6 , . 7207-1, 3.1.2. 3.7 , - ( ) . 4 4 21534 : , 4) 21534. , . 5 5.1 5 21534 . 5.
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5、4630. 11 , 11.1 11 14630 11.2 11.5. 11.2 , : ) ; ) , ( ) (. 7207-1) , , ; 215362013 4 ) , (. 7207-1) , , ; ) ( ). 11.3 : , , , / , , . - , , , . 11.4 - , , ( ): , , , . 11.5 11 21534. 215362013 5 () , A.1 . , . .2 / 1. 215362013 6 () A.1 ISO 7207-1:1994 IDT 7207-1-2005 . . 1. , ISO 14243-2:2009 IDT
